The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States.

It is generally believed that the Act accomplished both goals: encouraging development of new medications and accelerating market entry of generics.

Congress studied the issue and realized that under patent and regulatory law it was easy for innovator companies to make it difficult for generic companies to successfully file ANDAs, and that the regulatory pathway to get ANDAs approved was lengthy, expensive, and uncertain.

[4] The Act gives drug innovators some protection while facilitating and providing incentives for companies to file ANDAs.

[5][3] Passage of the law prompted a gold rush into the generic industry and a crush of applications, which the FDA was not prepared to handle.

[6] A series of scandals soon arose that shook public confidence in generic drugs; there were several instances in which companies obtained bioequivalence data fraudulently, by using the branded drug in their tests instead of their own product, and a congressional investigation found corruption at the FDA, where employees were accepting bribes to approve some generic companies' applications and delaying or denying others.